Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936286
• Other study ID #: WI_SpiroTiger_87/2008
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: March 9, 2010
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Idiag AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.

Description:

The obstructive sleep apnea syndrome (OSAS) is of great significance for affected individuals as well as for public health service. Patients suffer from reduced quality of life and show an increased accident risk in road traffic and on the job. Furthermore, OSAS represents an independent risk factor for cardiovascular diseases, in particular arterial hypertension.

In sleep apnea patients, the relatively early stimulation of the upper respiratory tract muscles compared to the thoracic respiratory muscles is abrogated in many cases. Alternatively, nerve damage with impaired sensory function in the pharynx area and impaired motor function of the upper air tract musculature, in particular the musculus genioglossus can be observed. The disturbed sensory function impairs the reflex activation of the genioglossus. Moreover, the pattern of neurogenic muscle damage with a loss of the pattern of different types of fibers changed to the point of adjoining atrophic and hypertrophic sections and a more monotonous appearance of fiber types could be detected. During waking hours the activity of the musculus genioglossus is enhanced compared with control persons, which is interpreted as a compensatory mechanism. During sleep time, however, this compensation seems to disappear.

In several studies either direct or indirect stimulation of the musculus genioglossus and its supplying nerves were deployed. Yet, the results were inconsistent. The direct muscle stimulation using intramuscular electrodes, although efficient, was no longer pursued due to technical reasons. Although the results of an external stimulation showed improvements regarding apneas and snoring, the findings were usually weakly pronounced. In a study ascertaining muscle training with transcutaneous electrical stimulation a significant improvement regarding snoring was achieved when compared to placebo. In general, no influence on sleep apnea syndrome could be accomplished, although there were individual cases showing a clinically relevant amelioration.

A preceding study compared habitual snorers with control persons. It was shown that respiratory muscle training by means of normocapnic hyperpnea was accompanied by enlargement of the musculus genioglossus and reduced snoring. Moreover, an increased physical performance was observed.

Thus, the question arises if training of the respiratory musculature by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Mild to intermediate sleep apnea syndrome with AHI of 10 - 30/h and clinical symptoms

• Refusal of a primary nCPAP therapy

• Epworth Sleepiness Scale (ESS) score = 9

• Signed informed consent form

Exclusion Criteria:

• Therapy with pharmaceuticals which can influence the musculature

• Psychiatric disease which negatively influences compliance

• Acute and chronic diseases of the lung and/or the respiratory passages

• BMI = 35 kg/m²

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• SpiroTiger
Respiratory muscle training with SpiroTiger device, 1 week training initiation and 4 weeks training period with 5 training days per week, training duration 30 min each. Respiratory bag volume set at 50% VC, respiratory frequency starting from 50% MVV. Weekly control trainings.

Locations

Country	Name	City	State
Germany	Wissenschaftliches Institut Bethanien e.V.	Solingen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Idiag AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index, Snoring		5 weeks	No
Secondary	Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count		5 weeks	No
Secondary	Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)		5 weeks	No
Secondary	Lung function test parameters (VC, FEV1, MVV, etc.)		5 weeks	No
Secondary	Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)		5 weeks	No